The Effect Of Botox In Patients With Gummy Smile With And Without Zinc And Phytase Supplementation.

NCT ID: NCT06577285

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-06-01

Brief Summary

Participants with esthetic concern of excessive gingival display who meets the inclusion criteria, will be carried out including history taking, clinical examination and initial therapy.

The initial therapy will consist of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques. Patients who have inadequate crown length and width ratio or short clinical crown will receive esthetic crown lengthening procedure to adjust gingival levels before being included in this study.

Patients in the intervention group I will take zinc gluconate 50 mg 1 per day to increase zinc level with phytase supplement 176mg (800FTU) 2 tablets per day to give the maximum absorption of zinc, both supplements will be given for 4 days before botulinum toxin injections. Patients in the intervention group II will take zinc gluconate 50 mg 1 per day to increase zinc level, 4 days before botulinum toxin injections.

Patients in the control group will receive the Botulinum toxin injections only Clinical photographs will be taken at baseline, 2 weeks, 1 month, 3 months postoperatively.

Detailed Description

Initial examination:

Participants with esthetic concern of excessive gingival display who meets the inclusion criteria, will be carried out including history taking, clinical examination and initial therapy.

The initial therapy will consist of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques.

Preoperative procedures:

Patients who have inadequate crown length and width ratio or short clinical crown will receive esthetic crown lengthening procedure to adjust gingival levels before being included in this study.

Clinical photographs:

Clinical photographs will be taken at baseline, 2 weeks, 1 month, 3 months postoperatively.

Intervention group I:

Patients in the intervention group I will take zinc gluconate 50 mg (Now food company) 1 per day to increase zinc level with phytase supplement 176mg (800FTU) (Goodphyte company) 2 tablets per day to give the maximum absorption of zinc, both supplements will be given for 4 days before botulinum toxin injections.

Intervention group II:

Patients in the intervention group II will take zinc gluconate 50 mg (Now food company) 1 per day to increase zinc level, 4 days before botulinum toxin injections.

Control group:

Patients in the control group will receive the Botulinum toxin injections only.

Botulinum toxin type A injection:

The patients will be injected at both sides into the "Yonsei point," (3Units) the point that would target 3 muscles responsible for upper lip elevation during smiling, including the levator labii superioris alaeque nasi (LLSAN), in a single injection. This landmark will be identified as the center of a triangle formed by the convergence of the LLSAN, the levator labii superioris (LLS), and the Zygomaticus minor muscles and is located 1 cm lateral to the ala horizontally and 3 cm above the lip line vertically in both men and women (Hwang et al. 2009) and (Nasr et al. 2015).

Postoperative care:

After Botox injection the patients will be instructed to:

1. Remain upright for 4 hours after injection (patients may lie in a reclined position, but not lay flat)

2. Refrain from aerobic exercise that increases the heart rate.

3. Not to massage or manipulate injected areas for 24 hours after injections,

4. Refrain from using ibuprofen, for 24 hours following injection.

5. If bruising appears, apply ice to area for 15 minutes every hour to decrease bruising.

Follow up:

Botox will gradually take effect over 7-10 days with optimum result at 2 weeks. After 2 weeks the patients would come for an additional touch up dose (1 unit at each injection point)

Conditions

Excessive Gingival Display

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention group I

Patients in the intervention group I will take zinc gluconate 50 mg (Now food company) 1 per day to increase zinc level with phytase supplement 176mg (800FTU) (Goodphyte company) 2 tablets per day to give the maximum absorption of zinc, both supplements will be given for 4 days before botulinum toxin injections.

Group Type: ACTIVE_COMPARATOR

zinc gluconate 50 mg with phytase supplement 176mg (800FTU)

Intervention Type: DIETARY_SUPPLEMENT

zinc gluconate 50 mg1 per day with phytase supplement 176mg (800FTU) (Goodphyte company) 2 tablets per day

Intervention group II

Patients in the intervention group II will take zinc gluconate 50 mg (Now food company) 1 per day to increase zinc level, 4 days before botulinum toxin injections.

Group Type: ACTIVE_COMPARATOR

zinc gluconate 50 mg

Intervention Type: DIETARY_SUPPLEMENT

zinc gluconate 50 mg 1 per day, 4 days before botulinum toxin injections.

Control group

Patients in the control group will receive the Botulinum toxin injections only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

zinc gluconate 50 mg with phytase supplement 176mg (800FTU)

zinc gluconate 50 mg1 per day with phytase supplement 176mg (800FTU) (Goodphyte company) 2 tablets per day

Intervention Type: DIETARY_SUPPLEMENT

zinc gluconate 50 mg

zinc gluconate 50 mg 1 per day, 4 days before botulinum toxin injections.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Patients with excessive gingival display >3mm and with normal clinical crown dimensions.

2. Adults >18 years.

3. Non-smokers.

4. Systemically healthy.

5. Hypermobile lip and mild VME.

Exclusion Criteria

1. Severe VME.

2. Pregnant or lactating females.

3. Patients with inflamed gingiva or gingival enlargement.

4. Inflammation or infection at the site of injection.

5. Patients with known allergy to any of the components of BTX-A or BTX-B (i.e. BTX, human albumin, saline, lactose and sodium succinate).

6. Patients using anticholinesterase or other agents interfering with neuromuscular transmission.

7. Psychologically unstable or who have questionable motives and unrealistic expectations.

8. Dependent on intact facial movements and expressions for their livelihood (e.g. actors, singers, musicians and other media personalities).

9. Afflicted with a neuromuscular disorder (e.g. myasthenia gravis, Eaton- Lambert syndrome).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mawda Mohamed Hussain Eltoum

Principle investigator Mawada Mohamed Master Degree Student, Periodontology department, Faculty of Dentistry, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weam A El-Battawy, Ass. Prof.

Role: STUDY_DIRECTOR

Cairo University

Mawda M Hussain, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Nesma F Shemais, lecturer

Role: STUDY_CHAIR

Cairo University

Locations

Faculty of Dentistry Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mawda M Hussain, Bachelor

Role: CONTACT

mawda.mohamed@dentistry.cu.edu.eg

+201501005110

Nesma F Shemais, lecturer

Role: CONTACT

nesma.shemais@dentistry.cu.edu.eg

+201005615697

Other Identifiers

18514PER3_3_1

Identifier Type: -

Identifier Source: org_study_id